Stretchable stent and delivery system

ABSTRACT

An implant delivery catheter enables permanent modification of the implant length in the vicinity of the treatment site prior to radial expansion thereof. The implant is releasable carried between inner and outer tubular members of the delivery catheter which, upon repositioning relative to one another using an actuator mechanism, impart any of tensile, compressile or torquing forces to the implant causing permanent modification of the implant length. In one embodiment, the circumference of the implant is substantially similar both before and after modification of the implant length. In another embodiment, the implant includes a plurality of strut sections interconnected by bridges which are capable of the deformation along the longitudinal axis of the implant.

FIELD OF THE DISCLOSURE

The present disclosure relates to an implant and a system for deliveringthe implant to a site in a body lumen. More particularly, thisdisclosure pertains to a vascular implant such as a stent.

BACKGROUND OF THE DISCLOSURE

Stents are widely used for supporting a lumen structure in a patient'sbody. For example, stents may be used to maintain patency of a coronaryartery, carotid artery, cerebral artery, other blood vessels includingveins, or other body lumens such as the ureter, urethra, bronchus,esophagus, or other passage.

Stents are commonly metallic tubular structures made from stainlesssteel, Nitinol, Elgiloy, cobalt chrome alloys, tantalum, and othermetals, although polymer stents are known. Stents can be permanentenduring implants, or can be bioabsorbable at least in part.Bioabsorbable stents can be polymeric, bio-polymeric, ceramic,bio-ceramic, or metallic, and may elute over time substances such asdrugs. Non-bioabsorbable stents may also release drugs over time. Stentsare passed through a body lumen in a collapsed state. At the point of anobstruction or other deployment site in the body lumen, the stent isexpanded to an expanded diameter to support the lumen at the deploymentsite.

In certain designs, stents are open-celled tubes that are expanded byinflatable balloons at the deployment site. This type of stent is oftenreferred to as a “balloon expandable” stent. Stent delivery systems forballoon expandable stents are typically comprised of an inflatableballoon mounted on a two lumen tube. The stent delivery system withstent compressed thereon can be advanced to a treatment site over aguidewire, and the balloon inflated to expand and deploy the stent.

Other stents are so-called “self expanding” stents and do not useballoons to cause the expansion of the stent. An example of aself-expanding stent is a tube (e.g., a coil tube or an open-celledtube) made of an elastically deformable material (e.g., a superelasticmaterial such a nitinol). This type of stent is secured to a stentdelivery device under tension in a collapsed state. At the deploymentsite, the stent is released so that internal tension within the stentcauses the stent to self-expand to its enlarged diameter.

Other self-expanding stents are made of so-called shape-memory metals.Such shape-memory stents experience a phase change at the elevatedtemperature of the human body. The phase change results in expansionfrom a collapsed state to an enlarged state.

A very popular type of self expanding stent is an open-celled tube madefrom self-expanding nitinol, for example, the Protege GPS stent fromev3, Inc. of Plymouth, Minn. Open cell tube stents are commonly made bylaser cutting of tubes, or cutting patterns into sheets followed by orpreceded by welding the sheet into a tube shape, and other methods.Another delivery technique for a self expanding stent is to mount thecollapsed stent on a distal end of a stent delivery system. Such asystem can be comprised of an outer tubular member and an inner tubularmember. The inner and outer tubular members are axially slideablerelative to one another. The stent (in the collapsed state) is mountedsurrounding the inner tubular member at its distal end. The outertubular member (also called the outer sheath) surrounds the stent at thedistal end.

Prior to advancing the stent delivery system through the body lumen, aguide wire is first passed through the body lumen to the deploymentsite. The inner tube of the delivery system is hollow throughout atleast a portion of its length such that it can be advanced over theguide wire to the deployment site. The combined structure (i.e., stentmounted on stent delivery system) is passed through the patient's lumenuntil the distal end of the delivery system arrives at the deploymentsite within the body lumen. The delivery system and/or the stent mayinclude radiopaque markers to permit a physician to visualize stentpositioning under fluoroscopy prior to deployment. At the deploymentsite, the outer sheath is retracted to expose the stent. The exposedstent is free to self-expand within the body lumen. Following expansionof the stent, the inner tube is free to pass through the stent such thatthe delivery system can be removed through the body lumen leaving thestent in place at the deployment site.

It can be difficult to estimate the length of the diseased portion of avessel and therefore the stent length needed for treatment of thedisease. This is particularly true for long diseased segments, segmentsthat are tortuous, and segments that are oriented at angles to the planeof the imaging modality used (due to image foreshortening). If the stentchosen for treatment is too long then un-diseased vessel will betreated, and if the stent chosen is too short then diseased vessel willbe untreated. Both of these scenarios are undesirable. In some casesphysicians will treat a portion of the length of the diseased vesselwith a first stent and will implant a second stent to treat theremainder of the length of the diseased vessel, overlapping the twostents to assure that no portion of the diseased vessel is leftuntreated. This approach is also undesirable because problems such ascorrosion between dissimilar metals, excessive vessel stiffening, stentfracture, and reduced stent fatigue life can arise at the site ofoverlap. Problems secondary to stent fracture can include pain,bleeding, vessel occlusion, vessel perforation, high restenosis rate,non-uniform drug delivery profile, non-even vessel coverage and otherproblems. Re-intervention may be required to resolve these problems.Further, use of multiple stents to cover a treatment site increasesprocedural time and cost.

Some have attempted to improve the precision with which to estimate theneeded implant length. For example, a guidewire having visualizablemarkers separated by a known distance can be inserted into the treatmentregion. However, these techniques have not become widespread in partbecause marker wires do not perform as well as the specialty guidewirespreferred by physicians.

What is needed is an implant and associated delivery system that permitsdelivery and deployment of stents that are well matched to the length ofdiseased segments.

SUMMARY OF THE DISCLOSURE

An implant delivery catheter enables permanent modification of theimplant length in the vicinity of the treatment site prior to radialexpansion thereof. The implant is releasable carried between inner andouter tubular members of the delivery catheter which, upon repositioningrelative to one another using an actuator mechanism, impart any oftensile, compressile or torquing forces to the implant causing permanentmodification of the implant length. In one embodiment, the circumferenceof the implant is substantially similar both before and aftermodification of the implant length. In another embodiment, the implantincludes a plurality of strut sections interconnected by bridges whichare capable of the deformation along the longitudinal axis of theimplant.

According to one aspect of the disclosure, an implant for insertion intoa body lumen comprises a plurality of cells at least partially definedby a plurality of struts and a plurality of bridges, selected of thecells disposed at proximal and distal ends of the implant and havingterminal ends attached thereto The implant has an initial length L1extending along a longitudinal axis and an initial circumference C1extending circumferencially about the longitudinal axis, wherein theimplant assumes a deformation circumference C2 having a value within 0%to 10% of a value of the initial circumference C1 following applicationof a deformation force to the terminal ends thereof.

According to a second aspect of the disclosure, a medical devicecomprises a tubular implant having first and second ends and extendingfor an initial length L1 along a longitudinal axis and an implantdelivery system. The implant delivery system comprises a catheter havingan outer tubular member disposed about an inner tubular member, thefirst end of the implant operatively secured to the outer tubular memberand the second end of the implant operatively secured to the innertubular member; and an actuator mechanism movably coupled to one of theouter tubular member and the inner tubular member for changing relativepositions of the outer tubular member and the inner tubular member alonga second axis substantially parallel with the longitudinal axis; whereinchanges in the relative positions of the outer tubular member and theinner tubular member change the initial length L1 of the implant to amodified length L2.

According to a third aspect of the disclosure, a method for placement ofan implant within a body lumen comprises: A) providing an implant havinga generally tubular shaped body defining a number of cells and extendingfor an initial continuous length L1 along an axis; B) advancing theimplant with a delivery catheter to a site within the body lumen; C)modifying the length L1 to a second continuous length L2 along the axiswith the delivery catheter prior to deployment at the site within thebody lumen, the number of cells defined by the tubular shaped body beingthe same for both length L1 and length L2; and D) initiating radialexpansion of the implant about the axis at the site within the bodylumen.

According to a fourth aspect of the invention, implant for insertioninto a body lumen comprises a tubular body extending for an initiallength L1 along a longitudinal axis and having and initial circumferenceC1 about the longitudinal axis. The tubular body further comprisesplurality of strut structures and a plurality bridge structurescollectively defining a plurality of cells, selected of the plurality ofcells being disposed at proximal and distal ends of the tubular body andhaving terminal ends attached thereto. One of the plurality of strutstructures and bridge structures are capable of deformation in adirection tending toward the longitudinal axis of the tubular body whena force, parallel to the longitudinal axis, is applied to the endterminals.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further advantages of the inventive concept may be betterunderstood by referring to the following description in conjunction withthe accompanying drawings in which:

FIGS. 1A and 1B illustrate plan views of an exemplary stretchableimplant embodiment having structure that interlocks with structure of astretchable implant delivery catheter. The implant is shown contractedand un-stretched in FIG. 1A and contracted and stretched in FIG. 1B. Theimplant and interlock structures are shown cut longitudinally and laidflat;

FIGS. 2A, 2B, 2C, 2D, 2E and 2F illustrate plan views of portions ofexemplary stretchable implants;

FIG. 2G is a graph illustrating certain characteristics of exemplarystretchable implant portion illustrated in FIG. 2F;

FIGS. 3A, 3B, 4A, and 4B illustrate characteristics of exemplarystretchable implants;

FIGS. 5A and 5B illustrate side elevation views of one embodiment of astretchable implant system having features that are examples ofinventive aspects in accordance with the principles of the presentdisclosure;

FIG. 5C illustrates a cross sectional view of the system of FIGS. 5A and5B;

FIGS. 5D, 5E and 5F illustrate side elevation partial cross sectionalviews of a portion of the stretchable implant system illustrated inFIGS. 5A to 5C;

FIGS. 5G and 5H illustrate enlarged views of the distal and proximalportions, respectively, of an alternate embodiment of a stretchableimplant system having features that are examples of inventive aspects inaccordance with the principles of the present disclosure;

FIG. 6 illustrates an enlarged view of the proximal portion of thesystem of FIG. 5A;

FIGS. 7A, 7B and 7C illustrate enlarged views of the distal portion ofthe system of FIG. 5A in various states of implant deployment;

FIGS. 8A and 8B illustrate enlarged views of the distal and proximalportions, respectively, of an alternate embodiment of a stretchableimplant system having features that are examples of inventive aspects inaccordance with the principles of the present disclosure;

FIGS. 9A and 9B illustrate enlarged views of the distal and proximalportions, respectively, of an alternate embodiment of a stretchableimplant system having features that are examples of inventive aspects inaccordance with the principles of the present disclosure;

FIG. 9C illustrates a cross sectional view of a portion of the system ofFIGS. 9A and 9B;

FIGS. 10A and 10B illustrate enlarged views of the distal and proximalportions, respectively, of an alternate embodiment of a stretchableimplant system having features that are examples of inventive aspects inaccordance with the principles of the present disclosure;

FIG. 11 illustrates an enlarged view of the distal portion of analternate embodiment of a stretchable implant system having featuresthat are examples of inventive aspects in accordance with the principlesof the present disclosure;

FIGS. 12A-C illustrate schematic views of the distal portion of thesystem of FIG. 11 in various states of implant deployment.

DETAILED DESCRIPTION

With reference now to the various drawing figures a description isprovided of embodiments that are examples of how inventive aspects inaccordance with the principles of the present disclosure may bepracticed. It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the broad inventive aspectsdisclosed herein. It will also be appreciated that while the inventiveconcepts disclosed herein are often described using stents as exemplaryimplants these inventive concepts are not limited to stents or to theparticular stent configurations disclosed herein, but are insteadapplicable to any number of different implant configurations.

In this specification various drawing figures and descriptions areprovided of embodiments that are examples of stretchable implants, thatis, implants that can be lengthened from a shorter length to a longerlength, generally by applying a tensile force to the ends of theimplant. It is contemplated that the implants described in the examplescan also be used as shortenable implants, that is, implants that can becompressed from a longer length to a shorter length by applying acompressile force to the ends of the implant. It is further contemplatedthat the implant delivery catheters, systems, and methods described foruse with stretchable implants are equally useful when applied toshortenable implants.

FIGS. 1A and 1B illustrate stretchable implant 10 comprised of struts12, bridges 14, and one or more tab 16 at each end 10 b, 10 a of implant10. The implant is shown cut longitudinally and laid flat. While eightrows of struts are illustrated in FIGS. 1A and 1B it is understood thatany number greater than two rows of struts are suitable for thedisclosure. Similarly, while fifteen struts per row are illustrated inFIGS. 1A and 1B it is understood that any number greater than threestruts per row are suitable for the disclosure. The perimeters enclosedby struts and bridges define cells 18. Struts are joined at bend regions13. In some embodiments tabs 16 are comprised of holes therethroughhaving markers 17 attached to tabs. Tabs 16 interlock with retainers ofstretchable implant delivery catheter (discussed below). Implant 10 canbe stretched along axis A by stretchable implant delivery catheter (alsodiscussed below).

Implant 10 has length L and circumference C, and includes a plurality ofstruts 12. At least some of the struts 12 have bend regions 13 withouttabs 16, or free terminal ends 15 that define proximal and distal ends10 a and 10 b of implant 10. Implant 10 includes interlock geometry inthe form of tabs 16 attached to or integral to one or more free terminalends 15 of struts 12. The tabs 16 project outwardly from the struts 12in a circumferential direction (i.e. in a direction coinciding with thecircumference C of the implant 10). Markers 17 are located adjacent theproximal or distal ends 10 a, 10 b or both of implant 10 and may belocated at any position along the length of the stent between theproximal and distal stent ends 10 a, 10 b. Markers 17 can be attached toimplant 10 by techniques such as adhesives, heat fusion, interferencefit, fasteners, intermediate members, as coatings, or by othertechniques. In one embodiment, markers 17 are comprised of radiopaquematerials press fit into a through-hole provided in tab 16. In oneembodiment, shown in FIGS. 1A and 1B, the tabs are circularenlargements. It will be appreciated that other shapes and otherinterlock configurations could also be used. Suitable designs of tabs 16and markers 17 include but are not limited to those described in FIGS.6A, 6B, 7 to 13, 14A, 14B, 15A and 15B and related discussions thereofin U.S. Pat. No. 6,623,518 entitled “Implant Delivery System withInterlock”, and include but are not limited to those described in FIGS.4 to 15 and related discussions thereof in U.S. Pat. No. 6,814,746entitled “Implant Delivery System with Marker Interlock”, the contentsof which being incorporated in their entirety herein by reference forall purposes.

In other embodiments markers 17 are comprised of ultrasonic markers, MRIsafe markers, or other markers. In one embodiment ultrasonic markers 17permit a physician to accurately determine the position of implant 10within a patient under ultrasonic visualization. Ultrasonicvisualization is especially useful for visualizing implant 10 duringnon-invasive follow-up and monitoring. Materials for ultrasonic marker17 have an acoustical density sufficiently different from implant 10 toprovide suitable visualization via ultrasonic techniques. Exemplarymaterials comprise polymers (for metallic stents), metals such astantalum, platinum, gold, tungsten and alloys of such metals (forpolymeric or ceramic stents), hollow glass spheres or microspheres, andother materials.

In another embodiment MRI safe markers permit a physician to accuratelydetermine the position of implant 10 within a patient under magneticresonance imaging. MRI visualization is especially useful forvisualizing implant 10 during non-invasive follow-up and monitoring.Exemplary materials for making MRI safe marker 17 have a magneticsignature sufficiently different from implant 10 to provide suitablevisualization via MRI techniques. Exemplary materials comprise polymers(for metallic stents), metals such as tantalum, platinum, gold, tungstenand alloys of such metals (for polymeric or ceramic stents), non-ferrousmaterials, and other materials.

Implant 10 may be comprised of metal, polymer, ceramic, permanentenduring materials, and may comprise either of or both ofnon-bioabsorbable and bioabsorbable materials. Exemplary materialsinclude but are not limited to Nitinol, stainless steel, cobalt chromiumalloys, Elgiloy, magnesium alloys, polylactic acid, poly glycolic acid,poly ester amide (PEA), poly ester urethane (PEU), amino acid basedbioanalogous polymers, tungsten, tantalum, platinum, polymers,bio-polymers, ceramics, bio-ceramics, or metallic glasses. Part or allof implant 10 may elute over time substances such as drugs, biologics,gene therapies, antithrombotics, coagulants, anti-inflammatory drugs,immunomodulator drugs, anti-proliferatives, migration inhibitors,extracellular matrix modulators, healing promoters,re-endothelialization promoters, or other materials. In one embodiment,implant 10 is comprised of shape memory urethane polymer. Implant 10 canbe manufactured by forming cells 18 through the wall of the tube, bymeans such as laser cutting, electrochemical etching, grinding,piercing, or other means. In some embodiments implant 10 is formed byelectroforming. In one embodiment, implant 10 can be manufactured bycutting (e.g., laser cutting) the various features from a solid tube ofsuperelastic Nitinol metal. In some embodiments implant 10 is finishedby processes to remove slag (such as microgrit blasting), to removeimplant material having a heat affected zone or other imperfections(e.g. by electropolishing), and to render surface of implant 10 moreresistant to corrosion (e.g. by surface passivation).

In other embodiments implant 10 may be comprised of intertwined, joined,or non-woven filaments. In some embodiments filaments are braided,woven, knitted, circular knitted, compressed, or otherwise fabricatedinto a porous mesh structure having cells 18. Filaments may be joined atone or more filament crossings by sintering, bonding, soldering, fusing,welding, or other means.

Implant 10 may have one or more of the following characteristics: selfexpanding, self contracting, balloon expandable, and shape memory. Inone embodiment implant 10 is comprised of balloon expandable stainlesssteel alloy. In another embodiment implant 10 is comprised ofsuperelastic nitinol struts 12 and non-superelastic malleable bridges14. In various embodiments implant 10 is a stent, a stent graft, a meshcovered stent, or other implants.

Implant 10 has un-stretched length L1 as illustrated in FIG. 1A andstretched length L2 as illustrated in FIG. 1B. In the examples of FIGS.1A and 1B bridges 14 can be lengthened along axis A in response totensile force applied to ends 10 a, 10 b of implant 10. Lengthening ofimplant 10 causes bridges 14 to align in a direction more parallel withstent axis A, thereby increasing distance D3 between free terminal endsand causing a small offset 11 between adjacent rows of struts 12.Lengthening of contracted implant 10 causes little or no change instretched circumference C2 as compared to un-stretched circumference C1.In some embodiments lengthened implants remain lengthened after removalof the tensile forces which caused the implant to lengthen. Implants areenvisioned which can be lengthened any incremental amount up to themaximum stretched length of the implant. Implants having a maximumstretched length L2 from 3% to 50% greater than the implant un-stretchedlength L1 are contemplated. In one embodiment, implant 10 has a maximumstretched length 5% greater than the implant un-stretched length. Inother embodiments, implant 10 has a maximum stretched length 10%, 15%,20%, 25%, 30%, 35%, 40%, or 45% greater than the implant un-stretchedlength. Implants having a stretched circumference C2 within 0% to 10% ofun-stretched circumference C1 are contemplated. In one embodiment,implant 10 has a maximum stretched circumference within 9% of theimplant un-stretched circumference. In other embodiments, implant 10 hasa maximum stretched circumference within 1%, 2%, 3%, 4%, 5%, 6%, 7%, or8% of the implant un-stretched circumference.

In some embodiments of stretchable implants, for example a metallicarterial stent, it is desirable to have the percentage of vessel innerwall area that is covered by the expanded metal stent (“percent metalcoverage”) to fall within a pre-programmed range. In one example a 6 mmdiameter by 100 mm long (6×100) stent is designed to be lengthened onlyby a maximum of 29%, to have a pre-programmed average percent metalcoverage of 14% at the nominal size of 6×100 and to have a percent metalcoverage of 14-18% over its indicated usable range. As illustrated inFIG. 3A, the exemplary stent, deployed at 100 mm long in a 6 mm vessel,has 14% metal coverage. The exemplary stent, deployed at 100 mm long ina 4.7 mm vessel, has 18% metal coverage ((14%/18%)*6 mm=4.7 mm). Theexemplary stent, deployed at 129 mm long in a 4.7 mm vessel, has 14%metal coverage ((18%/14%)*100 mm=129 mm) and deployed at 129 mm long ina 3.7 mm vessel, has 18% metal coverage ((14%/18%)*4.7 mm=3.7 mm). Theshaded region S1 in FIG. 3A describes the indicated usable range of thisexemplary stent when stretched. Stents deployed in vessels having alength and diameter combination within shaded region S1 will havepercent metal coverage of 14-18%.

In another example a 6 mm diameter by 100 mm long (6×100) stent isdesigned to be deployed in vessels having a limited diameter range (6 mmto 5.3 mm), be mainly stretchable but to a limited extent contractable,to have a pre-programmed average percent metal coverage of 14% at thenominal size of 6×100, and to have a percent metal coverage of 14-18%over it's indicated usable range. As illustrated in FIG. 3B, theexemplary stent, deployed at 100 mm long in a 6 mm vessel, has 16% metalcoverage. The exemplary stent, deployed at 114 mm long in a 6 mm vessel,has 18% metal coverage, and deployed at 88 mm long in a 6 mm vessel, has14% metal coverage. The exemplary stent, deployed at 100 mm long in a5.3 mm vessel, has 18% metal coverage and deployed at 129 mm long in a5.3 mm vessel, has 14% metal coverage. The shaded region S2 in FIG. 3Bdescribes the indicated usable range of this exemplary stent whenstretched and the shaded region C2 in FIG. 3B describes the indicatedusable range of this exemplary stent when contracted. Stents deployed invessels having a length and diameter combination within shaded regionsS2 and C2 will have percent metal coverage of 14-18%.

In other embodiments of stretchable implants it is desirable for aplurality of repeating units, such as a cell 18, to have similar or thesame axial and radial expansion or contraction characteristics, or both.In one embodiment the implant has similar axial and radial cellularexpansion characteristics so that the implant will uniformly stretch andwill uniformly expand. In FIGS. 4A and 4B, cell 18 of implant 10 isrepresented by cell 48. Cell 48 is shown unexpanded, cut longitudinallyand laid flat. In one embodiment of implant 10, when the implant isexpanded, representative cell 48 will expand from length 41 to length 42with little or no change to axial dimension 46 (FIG. 4A). In anotherembodiment (FIG. 4B), when implant 10 is first stretched and thenexpanded, representative cell 48 will first stretch from axial dimension46 to axial dimension 47 with little or no change to length 41, and willthen expand from length 41 to length 42 with little or no change toaxial dimension 47. Ratio's of expanded cell length 42 to unexpandedcell length 41 of from 200% to 800% are contemplated. In one embodiment,implant 10 has a ratio of expanded cell length to unexpanded cell lengthof 300%. In other embodiments, implant 10 has a ratio of expanded celllength to unexpanded cell length of 350%, 400%, 450%, 500%, 550%, 600%,675%, or 750%. Ratio's of stretched cell axial dimension 47 tounstretched cell axial dimension 46 of from 3% to 50% are contemplated.In one embodiment, implant 10 has a ratio of stretched cell axialdimension to unstretched cell axial dimension of 5%. In otherembodiments, implant has a ratio of stretched cell axial dimension tounstretched cell axial dimension of 10%, 15%, 20%, 25%, 30%, 35%, 40%,or 45%.

FIGS. 2A to 2E illustrate alternate embodiments of stretchable implants.FIG. 2A illustrates stretchable implant 20A comprised of struts 12 a,bridges 14 a, and one or more tabs 16 having markers 17. The implant isshown partially expanded, cut longitudinally and laid flat. Theperimeter of struts and bridges define cells 18 a. Struts are joined atbend regions 13 a. Implant 20A has substantially the same construction,dimensions, and function as implant 10 described above in conjunctionwith FIGS. 1A, 1B, 3A, 3B, 4A, and 4B. Implant 20A can be stretchedalong axis A by stretchable implant delivery catheter (discussed below).In one embodiment cross sectional area of bridges 14 a normal to axis Ais less than cross sectional area of struts 12 a normal to axis A andless than cross sectional area of tabs 16 normal to axis A. In oneembodiment bridges are locally thinned using processes such aselectroetching with or without use of masks, grinding, polishing, laserablation, or other processes. In another embodiment strut thickness isselectively increased by stiffening a particular region by means of anadditive process such as plating, electrodeposition, sputtering,coating, or other processes. In another embodiment yield force ofbridges 14 a normal to axis A is less than yield force of struts 12 anormal to axis A and less than yield force of tabs 16 normal to axis A.In a further embodiment cross sectional area of bridges 14 a normal toaxis A is less than cross sectional area of struts 12 a normal to axis Aand less than cross sectional area of tabs 16 normal to axis A and yieldforce of bridges 14 a normal to axis A is less than yield force ofstruts 12 a normal to axis A and less than yield force of tabs 16 normalto axis A. In some embodiments one or more bridge 14 a is comprised ofmalleable material such as annealed metal, engineering polymer, or othermaterials. Annealed metal may be produced by selectively heating bridges14 a using processes such as laser heating, electrical resistiveheating, inductive heating, or other processes.

In use, when tension is applied to implant 20A bridges 14 a lengthen inthe direction of axis A (i.e. dimension 21 increases) but struts 12 aand tabs 16 do not lengthen in the direction of axis A. In someembodiments bridges 14 a are permanently deformed by the applied tensileforces. After implant lengthening the implant is radially expanded. Inone embodiment implant 20A is a self expanding stent and the stent isallowed to self-expand by means of sheath removal. In another embodimentimplant 20A is a balloon expandable stent and the stent is expanded bymeans of balloon inflation. During implant 20A stretching and expansionimplant dimensional changes fall within the ranges disclosed for implant10 (above).

FIGS. 2B and 2C illustrate stretchable implants 20B, 20C comprised ofstruts 12 b, 12 c, bridges 14 b, 14 c, and one or more tabs 16 havingmarkers 17. The implants are shown partially expanded, cutlongitudinally and laid flat. The perimeter of struts and bridges definecells 18 b, 18 c. Struts are joined at bend regions 13 b, 13 c. Implant20A has substantially the same construction, dimensions, and function asimplant 10 described above in conjunction with FIGS. 1A, 1B, 3A, 3B, 4A,and 4B. Implants 20B and 20C can be stretched along axis A bystretchable implant delivery catheter (discussed below). Bridges 14 b,14 c are comprised of a serpentine shape and one or more gap 23. Theperimeter of struts and bridges define cells 18 b, 18 c. Struts arejoined at bend regions 13 b, 13 c. FIG. 2B illustrates stretchableimplant 20B comprised of bridges 14 b having one gap 23 and FIG. 2Cillustrates stretchable implant 20C comprised of bridges 14 c havingthree gaps 23. In other embodiments bridges can have serpentine shapeswith any number of bends and lengths along circular perimeter of stent.Bridges can also join one or more bend regions radially adjacent to eachother or can join one or more bend regions radially offset from eachother. In some embodiments one or more bridge 14 b, 14 c is comprised ofmalleable material such as annealed metal, engineering polymer, or othermaterial. In one embodiment yield force of bridges 14 b, 14 c normal toaxis A is less than yield force of struts 12 b, 12 c normal to axis Aand less than yield force of tabs 16 normal to axis A. In someembodiments one or more bridge 14 b, 14 c is comprised of malleablematerial such as annealed metal, produced by selectively heating bridges14 a using processes such as laser heating, electrical resistiveheating, inductive heating, or other processes. In another embodimentbridges are locally thinned using processes such as electroetching withor without use of masks, chemical milling, EDM, grinding, polishing,laser ablation, or other processes.

In use, when tension is applied to implant 20B, 20C gap(s) 23 in bridges14 b, 14 c widen in the direction of axis A but struts 12 b, 12 c andtabs 16 do not elongate in direction of axis A. In some embodimentsbridges 14 b, 14 c are permanently deformed by the applied tensileforces. After implant lengthening the implant is radially expanded. Inone embodiment implant 20B, 20C is a self expanding stent and the stentis allowed to self-expand by means of sheath removal. In anotherembodiment implant 20B, 20C is a balloon expandable stent and the stentis expanded by means of balloon inflation. During implant 20B, 20Cstretching and expansion implant dimensional changes fall within theranges disclosed for implant 10 (above).

FIGS. 2D and 2E illustrate stretchable implant 20D comprised of struts12 d, bridges 14 d, and one or more tabs 16 having markers 17. Theimplant is shown cut longitudinally and laid flat, also the implant isshown partially expanded in FIG. 2D and contracted to a deliveryconfiguration in FIG. 2E. The perimeter of struts and bridges definecells 18 d. Struts are joined at bend regions 13 d and follow aserpentine path along their length with one or more bend regions 24along the length of each strut. Implant 20D has substantially the sameconstruction, dimensions, and function as implant 10 described above inconjunction with FIGS. 1A, 1B, 3A, 3B, 4A, and 4B. Implant 20D can bestretched along axis A by stretchable implant delivery catheter(discussed below). In some embodiments one or more bend region 24 iscomprised of malleable material such as annealed metal. In oneembodiment yield force of bend region 24 normal to axis A is less thanyield force of struts 12 d normal to axis A and less than yield force oftabs 16 normal to axis A. In some embodiments one or more bend region 24is comprised of malleable material such as annealed metal, produced byselectively heating bend region 24 using processes such as laserheating, electrical resistive heating, inductive heating, or otherprocesses. In another embodiment bend points are locally thinned usingprocesses such as electroetching with or without use of masks, grinding,polishing, laser ablation, or other processes.

In use, when tension is applied to implant 20D struts 12 d straightenand lengthen in the direction of axis A due to deformation in bendregions 24. Tabs 16 do not lengthen when tension is applied. In someembodiments bend regions 24 are permanently deformed by the appliedtensile forces. After implant lengthening the implant is radiallyexpanded. In one embodiment implant 20D is a self expanding stent andthe stent is allowed to self-expand by means of sheath removal. Inanother embodiment implant 20D is a balloon expandable stent and thestent is expanded by means of balloon inflation. During implant 20Dstretching and expansion implant dimensional changes fall within theranges disclosed for implant 10 (above).

FIG. 2F illustrates a portion of stretchable implant 20F comprised ofstruts 12 f, bridges 14 f, proximal end 25 a (not shown), distal end 25b, and one or more tabs 16 having markers 17. The implant is showncontracted to a delivery configuration, cut longitudinally and laidflat. The perimeter of struts and bridges define cells 18 f. Struts arejoined at bend regions 13 f, are malleable at least in part, and areoriented at twist angle α relative to axis A. Implant 20F hassubstantially the same construction, dimensions, and function as implant10 described above in conjunction with FIGS. 1A, 1B, 3A, 3B, 4A, and 4B.In one embodiment torsional yield force of struts 12 f and bridges 14 fis less than torsional yield force of tabs 16. In some embodiments oneor more strut 12 f and bridge 14 f is comprised of malleable materialsuch as annealed metal, produced by selectively heating strut 12 fand/or bridge 14 f using processes such as laser heating, electricalresistive heating, inductive heating, or other processes. In anotherembodiment struts 12 f and/or bridges 14 f are locally thinned usingprocesses such as electroetching with or without use of masks, grinding,polishing, laser ablation, or other processes. Implant 20F can belengthened along axis A by stretchable implant delivery catheter(discussed below) by twisting proximal end 25 a (not shown) relative todistal end 25 b in a direction that reduces twist angle α. In oneembodiment, a stent having a length of 71 mm when α=45° can belengthened by any incremental amount by twisting proximal end 25 a (notshown) relative to distal end 25 b in a direction that reduces twistangle α, to a maximum length when α=0°. For one embodiment where implant20F is a 100 mm long stent when fully stretched, FIG. 2G illustratesstent length vs. stent twist angle.

In use, when proximal end 25 a (not shown) of implant 20F is twistedrelative to distal end 25 b of implant in a direction that reduces twistangle α, struts 12 f become oriented in a direction more parallel toaxis A, thereby lengthening the implant the direction of axis A. In someembodiments malleable struts 12 f and bend regions 13 f are permanentlydeformed by the applied torsional forces. After implant lengthening theimplant is radially expanded. In one embodiment implant 20F is a selfexpanding stent and the stent is allowed to self-expand by means ofsheath removal. In another embodiment implant 20F is a balloonexpandable stent and the stent is expanded by means of ballooninflation. During implant 20F stretching and expansion implantdimensional changes fall within the ranges disclosed for implant 10(above).

In some embodiments the implant when stretched will lengthenpreferentially in certain regions along the length of the implant. Forexample, implants 10, 20A, 20B and 20C tend to lengthen in the regionadjacent to bridges 14, 14 a, 14 b and 14 c respectively. When expanded,implants 10, 20A, 20B and 20C will have a structure that may becharacterized as a series of linearly separated serpentine ringsinterconnected by axial bridges. In one example deployed implants 10,20A, 20B and 20C are stretched more in the distal superficial femoralartery where challenging fatigue conditions are prevalent and stretchedless in the mid and proximal superficial femoral artery where fatigueconditions are less challenging. In another example deployed implants10, 20A, 20B and 20C are stretched more in the region of a previouslydeployed stent so as to minimize vessel stiffening in the alreadystiffened portion of the vessel and stretched less in the regionsproximal to and distal to the previously deployed stent so as to provideadequate vessel scaffolding in the previously unstented region of thevessel. In other embodiments the implant when stretched will lengthenthe majority of cells along the length of the implant. For example, eachcell 18 d, 18 f of implants 20D and 20F tend to lengthen in similaramounts when the implant is stretched. In the case of stent implants,structures similar to implants 20D and 20F may be advantageous bymaintaining a uniform percent metal coverage over the length of thestent.

In some embodiment's stretchable implant 10, 20A, 20B, 20C, 20D, or 20Foffers advantages when comprised of biologically active drugs in theform of coatings, bound moieties, elutable molecules, or other formsover some or all of the implant. In one embodiment a uniformly coatedimplant is deployed with more implant structure (such as unstretchedstent) in one region of the treatment site and less implant structure(such as stretched stent) in a second region of the treatment site,thereby allowing more drug to be delivered in the first region ascompared to that delivered in the second region. In another embodiment auniformly coated implant is deployed with more implant structure in oneregion of the treatment site and less implant structure in a secondregion of the treatment site, thereby allowing the structure in thesecond region to be driven more deeply into the treatment site ascompared to the structure in the first region, allowing differentkinetics of drug delivery in the two regions. In yet another embodiment,a stretchable implant can be comprised of drugs confined in a brittlecoating that is cracked on stretching of the implant. Said coating canisolate reactive drugs from each other, can provide barrier functionsfor improved drug shelf life, can confine liquids, or have otherfunctions. In one example a stretchable implant comprised of brittlecoating is stretched prior to deployment over at least a portion of it'slength to alter drug release kinetics from the coating. In anotherexample a stretchable implant comprised of brittle coating is stretchedover at least a portion of it's length prior to deployment to fracturereservoirs of two or more drugs that will react with one another so asto form a more desirable bioreactive species. In another example astretchable implant comprised of brittle coating is stretched over atleast a portion of its length prior to deployment to fracture reservoirsof two or more drugs that desirable are delivered simultaneously to atreatment site.

FIGS. 5A, 5B and 5C illustrate stretchable implant system 50 comprisedof catheter 51 having stretchable stent 54 mounted on distal region 50 dof catheter. Catheter 51 is comprised of catheter shaft 52, manifold 56,and retainers 55 p and 55 d. System 50 is configured to be advancedthrough the patient's body lumen. In use, system 50 is sufficiently longfor distal region 50 d to be placed at the deployment site in thepatient's body lumen with proximal region 50 p remaining external to thepatient's body for manipulation by an operator. Working length ofcatheter 51, defined as the catheter length distal to manifold 56, iscontemplated to be from 60 to 200 cm. Stretchable stent 54 has proximalend 54 p, distal end 54 d, is balloon expandable, and is secured tocatheter 51 by crimping the stent to a delivery diameter onto balloon 59with interlock of stent tabs 16 into pockets of retainers 55 p and 55 d.Stretchable stent 54 may be but is not limited to any of the stretchablestents 10, 20A, 20B, 20C, 20D, or 20F discussed previously andunstretched stent 54 lengths of from 20 mm to 400 mm are contemplated.Catheter shaft 52 is fixedly attached to proximal retainer 55 p.Manifold 56 is attached to proximal region 50 p of catheter shaft 52 andprovides means for attachment of a stent expansion device and means forstretching stent 54. A guidewire channel (not shown in FIGS. 5A and 5B),extending from distal region 50 d to proximal region 50 p, is optionallyprovided in catheter shaft 52. FIG. 5C illustrates further that catheter51 is comprised of bilumen inner member 57 having balloon inflationlumen 62, guidewire lumen 61, tip 58, distal retainer 55 d, and havingballoon 59 sealingly attached thereto at bonds 59 p, 59 d. Tip 58 anddistal retainer 55 d are fixedly attached to distal portion of bilumeninner member 57. Lumen 62 is in fluid communication with interior ofballoon 59. Bilumen inner member 57 is slideable within catheter shaft52 and attached retainer 55 p

Catheter shaft 52 of system 50 may have a variety of differentconstructions. Shaft 52 may have a tubular construction adapted toresist kinking, traverse through tortuous passageways, and to transmitaxial and in some embodiments torsional forces along the length of theshaft. Shaft 52 may be constructed so as to have varying degrees offlexibility along its length, and may be comprised of nylon, PEBAX,polyester, Polyurethane, PVC, PEEK, liquid crystal polymer, polyimide,braid reinforcement, metal reinforcement, or other materials. In oneembodiment, shaft 52 has a tubular construction of braid-reinforcedpolyester. Inner member 57 of system 50 is relatively flexible inbending, resists kinking, has high column stiffness and in someembodiments has high torsional stiffness. Inner member 57 may becomprised of nylon, PEBAX, polyester, PEEK, liquid crystal polymer,polyimide, braid reinforcement, metal reinforcement, or other materials.In one embodiment, inner member 57 has a bilumen tubular configuration,defining one lumen 61 that extends through an entire length of innermember 57 and one lumen 62 that extends through most of a length ofinner member 57. This type of configuration allows the system to bepassed over a guidewire for guiding the system to a desired implantdeployment location and allows inflation of balloon 59. However, inother embodiments, inner member 57 can have a single lumen configurationthat provides for balloon inflation only. Distal region 50 d of system50 includes a tapered and flexible distal tip 58 that is sufficientlyflexible to permit advancement of stretchable implant system 50 througha patient's lumen while minimizing trauma to the walls of the patient'slumen. Tip 58 may be comprised of PEBAX, PVC silicone rubber, C-Flex,polyurethane, thermoplastic elastomer, polyfluoroethylene, hydrogenated(styrene-butadiene) copolymer, or other materials and may be connectedto inner member 57 by bonding, overmolding, adhesives, or other means.Proximal facing edges of tip may be chamfered so as to reduce thepossibility of snagging on an implant during proximal withdrawal of thetip through the implant. Balloon 59 is capable of expanding a balloonexpandable stent at inflation pressures as high as 10, 14, 18, or 20atmospheres and may be comprised of biaxially oriented polymers such asnylon, PEBAX, polyester, or other materials. Balloon 59 is sealinglyattached to inner member 57 at bonds 59 p and 59 d using processes suchas laser welding, heat bonding, adhesive bonding, or other processes asare known to those skilled in the art. Distal and proximal retainers 55d, 55 p are attached to inner member 57 and shaft 52 respectively andhave sufficient strength to stretch stent 54 without mechanical failure.Distal and proximal retainers 55 d, 55 p in the form of separate piecescan be secured to inner member 57, and proximal facing edges of distalretainer may be chamfered so as to reduce the possibility of snagging onan implant during proximal withdrawal of the retainer through theimplant. Retainers 55 d, 55 p can be machined, etched, stamped, formed,injection molded from thermoplastics or metals, or otherwise fabricatedinto the surface of a ring of metal, engineering polymer, ceramic, orother material and the ring applied to inner member 57 and shaft 52 byadhesive bonding, welding, solvent welding, fusing, or other techniquesknown in the art. In some embodiments one or both of distal and proximalretainers 55 d, 55 p are formed as an integral/unitary structure withinner member 57 and shaft 52 respectively. In one embodiment one or bothof retainers 55 p, 55 d are provided with inclined surface 55 x thatprevents tab 16 from exiting out of retainer when stent is tensionedalong axis A (FIG. 5D). In another embodiment one or both of retainers55 p, 55 d are provided with inclined surface 55 y that prevents tab 16from exiting out of retainer when stent is compressed along axis A (FIG.5E). In yet another embodiment one or both of retainers 55 p, 55 d areprovided with inclined surfaces 55 x and 55 y that prevent tab 16 fromexiting out of retainer when stent is tensioned or compressed along axisA (FIG. 5F). Further, in some embodiments the minimum opening distancebetween inclined surfaces 55 x and 55 y is less than the correspondingdimension of tab 16 to prevent tab 16 from exiting out of retainer whenstent is neither in tension nor in compression. In said embodimentsstent is forced out of retainers 55 d, 55 p by the expanding force ofballoon 59 against stent 54. Alternatively, pockets of retainers 55 p,55 d can be filled with an adhesive or a space filling substance (notshown) to prevent exit of tab 16 from retainer 55 d, 55 p when stent isin tension, in compression, or in neither. Said substance may becomprised of polymers such as polyethylene, polyurethane, polybutylene,PEBAX, bioabsorbable polymers such as polyethylene oxide, Carbowax,malleable metals, or other materials.

Lumen 61 slideably receives a guidewire (not shown) and is dimensionedto allow low friction passage of a guidewire therewithin. Guidewiressuitable for use with system 50 have a nominal outer diameter of 0.010″,0.012″, 0.014″, 0.018″, 0.025″, 0.035″, 0.038″, or other diameters.Catheter shaft 52 maximum outside diameter can range from about 3 Fr toabout 10 Fr. A catheter shaft 52 outside diameter of about 5 Fr isdesirable for compatibility with currently popular guide catheter (notshown) dimensions. In one embodiment catheter working length is about145 cm.

FIG. 6 illustrates manifold 56 at proximal region 50 p of stretchableimplant system 50. Manifold 56 is comprised of Y-fitting 63, advancer64, and flange 65. Outer surface of proximal most portion of innermember 57 is sealingly attached to inner wall 63 g of Y-fitting 63proximal to lumen 62 a, and outer surface of inner member 57 issealingly attached to inner wall 63 b of Y-fitting 63 distal to lumen 62a. Lumen 62 of inner member 57 is in fluid communication with lumen 62 aof Y-fitting 63 and lumen 61 of inner member 57 is in fluidcommunication with lumen 61 a of Y-fitting 63. Y-fitting 63 is comprisedof standard luer fittings 66 b, 66 g at proximal end of lumens 62 a, 61a respectively. Shaft 52 is fixedly attached to flange 65, flange isheld captive within groove 64 a of advancer 64, flange is slideablewithin groove 64 a and flange is slideable over inner member 57 by meansof through hole 65 a. In an alternate embodiment where length ofstretchable stent is changed by applying torque to the stent, flange 65is fixedly bonded to advancer 64. Advancer is slideably attached toY-fitting 63 by means of threads 64 t and 63 t integral with advancer 64and Y-fitting 63 respectively. Rotation of advancer 64 displacescatheter 52 relative to inner member 57, causing tensile or compressileforces to be transmitted through retainers 55 p, 55 d and tabs 16 toimplant 54. In one embodiment manifold 56 is comprised of one or moreindicators which display one or more of implant stretched, nominal, orcompressed length.

Y-fitting 63, advancer 64, and flange 65 may be comprised ofpolycarbonate, polystyrene, or other materials. Alternate materials forthese components are generally well known in the art can be substitutedfor any of the non-limiting examples listed above provided thefunctional requirements of the component are met. Inner member 57 may besealingly attached to Y-fitting 63 using adhesives, welding, or othermeans as are known in the art. Catheter shaft 52 may be attached toflange 65 using adhesives, welding, or other means as are known in theart. Advancer/Y-fitting threaded connection is provided with sufficientaxial travel to stretch and/or contract stent 54 over the entire designrange of the stent. Optionally, a strain relief (not shown) may beattached to catheter shaft 52, flange 65, or both to prevent kinking ofsystem 50 in the region proximate flange 65. Optionally, an access portand sealing means (not shown) may be provided on flange 65 so that fluidcan be injected into the system to displace air from the annular spacebetween inner member 57 and catheter shaft 52.

Exemplary methods of using stretchable implant system 50 in a body of apatient are now described with the assistance of FIGS. 7A, 7B and 7C.While a stent is chosen as the exemplary implant in the methods it isunderstood that the disclosure is not limited to stent implants.

Using techniques well known in the art, a guidewire GW is percutaneouslyinserted into a patient's blood vessel V and advanced to a region ofinterest in the patient's body. Using imaging techniques such asfluoroscopy the diseased portion D of the vessel is identified and astretchable stent system comprised of a stretchable stent 54 having thecorrect length range and diameter range for treating the diseasedportion D is chosen. Stretchable implant system 50 is advanced over theguidewire to the treatment site and by using imaging techniques such asfluoroscopy, markers 17 at distal end 54 d of stent 54 are positioned ata correct location relative to the diseased portion D (FIG. 7A). Markers17 at proximal end 54 p of stent 54 are then imaged and by rotatingadvancer 64 stent 54 is stretched or contracted to the desired length asevidenced by positions of proximal and distal markers relative todisease length D (FIG. 7B).

Stretchable implant system 50 is held stationary, an inflation device(not shown) is attached to luer fitting 66 b and used to inflate balloon59. Inflated balloon expands stent 54 into contact with lumenal wall ofvessel V, and balloon is then deflated using inflation device. Catheter51 is repositioned such that balloon is within any unexpanded orunderexpanded portion of stent 54, balloon is reinflated andsubsequently deflated as many times as are needed to effect satisfactorystent contact with lumenal wall of vessel V. System 50 is then withdrawnfrom vessel V (FIG. 7C).

An alternative exemplary method of using a stretchable implant system 50in a body of a patient is now described. Using techniques well known inthe art, percutaneous access to a patient's blood vessel V isestablished. Using imaging techniques such as fluoroscopy the diseasedportion of the vessel is identified and a stretchable stent systemcomprised of a stretchable stent 54 having the correct length range anddiameter range for treating the diseased portion D is chosen. Aguidewire is either back-loaded or front-loaded into lumen 61 ofstretchable implant system 50 and the position of the guidewire isadjusted such that a short length (typically 10-20 cm) of the guidewireextends distally of tip 58. The system/guidewire combination is advancedthrough the patient's vessel to a region of interest in the patient'sbody. The combination is advanced to the treatment site and by usingimaging techniques such as fluoroscopy markers 17 at distal end 54 d ofstent 54 are positioned at a correct location relative to the diseasedportion D. Alternatively, the treatment site is initially crossed byfurther advancement of the guidewire alone, stretchable implant system50 is subsequently advanced over the guidewire to the treatment site andby using imaging techniques such as fluoroscopy, markers 17 at distalend 54 d of stent 54 are positioned at a correct location relative tothe diseased portion D. Markers 17 at proximal end 54 p of stent 54 arethen imaged and by rotating advancer 64 stent 54 is stretched orcontracted to the correct length as evidenced by positions of proximaland distal markers relative to disease length D.

Fitting/advancer of stretchable implant system 50 is held stationary, aninflation device is attached to luer fitting 66 b and used to inflateballoon 59. Inflated balloon expands stent 54 into contact with lumenalwall of vessel V, and balloon is then deflated using inflation device.Catheter 51 is repositioned such that balloon is within any unexpandedor underexpanded portion of stent 54, balloon is reinflated, andsubsequently deflated as many times as are needed to effect satisfactorystent contact with lumenal wall of vessel V. System 50 is then withdrawnfrom vessel V.

FIGS. 5G and 5H illustrate stretchable implant system 50′, similar inmany respects to stretchable implant system 50, and comprised ofcatheter 51′ having stretchable stent 54 mounted on distal region 50 d′of catheter. Catheter 51′ is comprised of catheter shaft 52, manifold56′, and retainers 55 p′ and 55 d. System 50′ is configured to beadvanced through the patient's body lumen. In use, system 50′ issufficiently long for distal region 50 d′ to be placed at the deploymentsite in the patient's body lumen with proximal region 50 p′ remainingexternal to the patient's body for manipulation by an operator. Workinglength of catheter 51′, defined as the catheter length distal tomanifold 56′, is contemplated to be from 60 to 200 cm. Stretchable stent54 has proximal end 54 p, distal end 54 d, is balloon expandable, and issecured to catheter 51′ by crimping the stent to a delivery diameteronto balloon 59′ with interlock of stent tabs 16 into pockets ofretainers 55 p′ and 55 d. Stretchable stent 54 may be but is not limitedto any of the stretchable stents 10, 20A, 20B, 20C, 20D, or 20Fdiscussed previously and unstretched stent 54 lengths of from 20 mm to400 mm are contemplated. Catheter shaft 52 is fixedly attached toproximal retainer 55 p′ and corrugated balloon 59′ is attached toproximal retainer 55 p′ at bond 59 p′. Manifold 56′ is attached toproximal region 50 p′ of catheter shaft 52 and provides means forattachment of a stent expansion device and means for stretching stent54. A guidewire channel extending from distal region 50 d′ to proximalregion 50 p′ is optionally provided in catheter shaft 52. Catheter 51′is comprised of single lumen inner member 57′ having guidewire lumen 61,tip 58, distal retainer 55 d, and having balloon 59′ sealingly attachedthereto at bond 59 d. Balloon lumen 62 is formed by the annular spacebetween the outer diameter of inner member 57′ and the inner diameter ofcatheter shaft 52. Tip 58 and distal retainer 55 d are fixedly attachedto distal portion of inner member 57′. Lumen 62 is in fluidcommunication with interior of balloon 59′. Inner member 57′ isslideable within catheter shaft 52 and attached retainer 55 p′.

Retainer 55 p′, inner member 57′, and bond 59 p′ have substantially thesame construction, dimensions, and function as retainer 55 p, innermember 57, and bond 59 p respectively described above in conjunctionwith FIGS. 5A to 5C, as do all components having the same numbers inFIGS. 5A to 5C and 5G to 5H. Balloon 59′ is capable of expanding aballoon expandable stent at inflation pressures as high as 10, 14, 18,or 20 atmospheres and has corrugations formed into the balloon duringthe balloon blowing process such that balloon is capable of stretchingaxially as stent is stretched prior to stent radial expansion. Balloon59′ may be comprised of biaxially oriented polymers such as nylon,PEBAX, polyester, polyurethane or other materials in monolithic orlayered structures. Balloon 59 is sealingly attached to inner member 57at bond 59 d and to proximal retainer 55 p at bond 59 p using processessuch as laser welding, heat bonding, adhesive bonding, or otherprocesses as are known to those skilled in the art.

FIG. 5H illustrates manifold 56′ at proximal region 50 p′ of stretchableimplant system 50′. Manifold 56′ is comprised of Y-fitting 63′, advancer64, and flange 65′. Outer surface of proximal most portion of innermember 57′ is sealingly attached to inner wall 63 g of Y-fitting 63proximal to lumen 62 a. Lumen 62 of catheter 51′ is in fluidcommunication with lumen 62 a of Y-fitting 63 and lumen 61 of innermember 57′ is in fluid communication with lumen 61 a of Y-fitting 63.Y-fitting 63 is comprised of standard luer fittings 66 b, 66 g atproximal end of lumens 62 a, 61 a respectively. Shaft 52 is fixedlyattached to flange 65′, flange is held captive within groove 64 a ofadvancer 64, flange is slideable within groove 64 a and flange isslideable over inner member 57 by means of through hole 65 a. Flange 65′has proximal extension 65 b with seal 67 housed in a groove in proximalextension 65 b. Seal 67 creates a fluid tight axially slideable sealbetween exterior diameter of proximal extension 65 b and inner diameterof counterbore 63 c in Y-fitting 63. Advancer is slideably attached toY-fitting 63 by means of threads 64 t and 63 t integral with advancer 64and Y-fitting 63 respectively. Rotation of advancer 64 displacescatheter 52 relative to inner member 57′, causing tensile or compressileforces to be transmitted through retainers 55 p, 55 d and tabs 16 toimplant 54 and balloon 59′. In one embodiment manifold 56 is comprisedof one or more indicators which display one or more of implantstretched, nominal, or compressed length.

Y-fitting 63′, advancer 64, and flange 65′ have substantially the sameconstruction, dimensions, and function as Y-fitting 63, advancer 64, andflange 65 respectively described above in conjunction with FIGS. 5A to5C. Optional strain relief, access port and sealing means, or both maybe provided on flange 65′ as described above in conjunction with FIG. 6.Seal 67 may be comprised of elastomeric materials such as butyl rubber,silicone rubber, Viton, C-flex, PVC, polyurethane, or other materialsand may be molded, cut from sheet, or made using other processes knownin the art.

Exemplary methods of using stretchable implant system 50′ in a body of apatient are identical to those for stretchable implant system 50 withthe following exceptions. When advancer 64 is rotated both the stent 54and the balloon 59′ will be stretched or contracted. Also, the initialballoon will expand substantially all of the length of the stretchablestent due to the length change of the balloon when the advancer isrotated. For this reason catheter 51′ may not need to be repositioned toeffect satisfactory stent contact with lumenal wall of vessel V.

FIGS. 8A and 8B illustrate the distal and proximal ends respectively ofan alternate embodiment of a stretchable implant system. Stretchableimplant system 70 is comprised of catheter 71 having stretchable stent74 mounted on distal region 70 d of catheter. Catheter 71 is comprisedof catheter shaft 72, proximal retainer 75 p, and manifold 76. Workinglength of catheter, defined as the catheter length distal to manifold76, is contemplated to be from 60 to 200 cm. Catheter 71 is furthercomprised of inner member 77 having single lumen proximal tube 77 b,single lumen extension tube 77 s, bitumen distal tube 77 g havingballoon inflation lumen 82, having guidewire lumen 81 and having balloon79 sealingly attached thereto at bonds 79 p and 79 d, track 77 j, tip78, and distal retainer 75 d. Tip 78 and distal retainer 75 d arefixedly attached to distal tube 77 g. Single lumen proximal tube 77 b,single lumen extension tube 77 s, and bitumen distal tube 77 g arefixedly attached to track 77 j. Lumen 82 is in fluid communication withinterior of balloon 79. Proximal retainer 75 p is slideable over track77 j and extension tube 77 s is slideable within lumen 72 b of bitumendistal portion of catheter shaft 72. Guidewire lumen 81 extends fromdistal region 70 d of catheter to catheter port 72 s. Stretchable stent74 has proximal end 74 p, distal end 74 d, is balloon expandable, and issecured to catheter shaft 72 by crimping the stent to a deliverydiameter onto balloon 79 with interlock of stent tabs 16 into pockets ofretainers 75 p and 75 d. Stretchable stent 74 may be but is not limitedto any of the stretchable stents 10, 20A, 20B, 20C, 20D, or 20Fdiscussed previously and unstretched stent lengths of from 20 mm to 400mm are contemplated. Manifold 76 is attached to proximal region 70 p ofcatheter and provides means for attachment of a stent expansion deviceand means for stretching stent 74.

Catheter shaft 72, retainer 75 p, inner member 77 (including tubes 77 b,77 g, 77 s and track 77 j), lumen 81, balloon 79, bonds 79 p and 79 d,tip 78, and retainer 75 d have substantially the same construction,dimensions, and function as catheter shaft 52, retainer 55 p, innermember 57, lumen 61, balloon 59, bonds 59 p and 59 d, tip 58, andretainer 55 d respectively described above in conjunction with FIGS. 5Ato 5C. Track 77 j may be comprised of polymers and may be manufacturedusing processes such as insert molding or reflow techniques.

FIG. 8B illustrates manifold 76 at proximal region 70 p of stretchableimplant system 70. Manifold 76 is comprised of fitting 83, advancer 84,and flange 85. Outer surface of proximal portion of tube 77 b issealingly attached to inner wall 83 b of fitting 83. Lumen 82 of tube 77b is in fluid communication with lumen 82 a of fitting 83. Fitting 83 iscomprised of standard luer fitting 86 b at proximal end of lumens 82 a.Shaft 72 is fixedly attached to flange 85, flange is held captive withingroove 84 a of advancer 84, flange is slideable within groove 84 a andflange is slideable over tube 77 b by means of through hole 85 a. In analternate embodiment where length of stretchable stent is changed byapplying torque to the stent, flange 85 is fixedly bonded to advancer84. Advancer is slideably attached to fitting 83 by means of threads 84t and 83 t integral with advancer 64 and fitting 83 respectively.Rotation of advancer 84 displaces shaft 72 relative to inner member 77,causing tensile or compressile forces to be transmitted throughretainers 75 p, 75 d and tabs 16 to implant 74.

Fitting 83, advancer 84, and flange 85 have substantially the sameconstruction, dimensions, and function as Y-fitting 63, advancer 64, andflange 65 respectively described above in conjunction with FIG. 6. Tube77 b and shaft 72 are attached to fitting 83 and flange 85 respectivelyin substantially the manner as inner member 57 and catheter 52 areattached to Y-fitting 63 and flange 65 respectively described above inconjunction with FIG. 6. Optional strain relief, access port and sealingmeans, or both may be provided on flange 85 as described above inconjunction with FIG. 6.

Exemplary methods of using stretchable implant system 70 are the same asthe exemplary methods described above for using stretchable implantsystem 50.

FIGS. 9A, 9B and 9C illustrate the distal and proximal portionsrespectively of an alternate embodiment of a stretchable implant system.Stretchable implant system 90 is comprised of catheter 91 havingstretchable stent 94 mounted on distal region 90 d of catheter. Catheter91 is comprised of catheter shaft 92, retainer 95 p, manifold 96 andsheath 93. Catheter shaft 92 is fixedly attached to retainer 95 p.Working length of catheter 91, defined as the catheter length distal tohandle 106, is contemplated to be from 60 to 200 cm. Catheter 91 isfurther comprised of inner member 97 having guidewire lumen 101, tip 98,and distal retainer 95 d. Tip 98 and distal retainer 95 d are fixedlyattached to inner member 97. Retainer 95 p is slideable over innermember 97 and sheath 93 is slideable over catheter shaft 92 and stent94. Guidewire lumen 101 extends from distal region 90 d of catheter tomanifold 96. Stretchable stent 94 has proximal end 94 p, distal end 94d, is self expandable, and is secured to catheter 91 by compressing thestent to a delivery diameter within sheath 93 with interlock of stenttabs 16 into pockets of retainers 95 p and 95 d. Stretchable stent 94may be but is not limited to any of the stretchable stents 10, 20A, 20B,20C, 20D, or 20F discussed previously and unstretched stent lengths of20 mm to 400 mm are contemplated. Manifold 96 is attached to proximalregion 90 p of catheter, provides means for withdrawal of sheath 93 fromstent 94, and provides means for stretching stent 94.

Catheter shaft 92, retainer 95 p, inner member 97, lumen 101, tip 98,and retainer 95 d have substantially the same construction, dimensions,and function as catheter shaft 52, retainer 55 p, inner member 57, lumen61, tip 58, and retainer 55 d respectively described above inconjunction with FIGS. 5A to 5C. Sheath is fixedly attached to handle106, has sufficient distal hoop strength to constrain self expandingstent 94 at a delivery diameter, has sufficient axial strength to beslid proximally off of stent 94 without damage or tensile failure, andsufficient flexibility to be advanced as part of system 90 throughtortuous vessels. Sheath 93 may be comprised of polyester, nylon, PEEK,liquid crystal polymer, polyimide, metal reinforcement, or othermaterials and may be manufactured at least in part by extrusion,braiding, joining of tubing lengths, or other processes known in theart.

FIG. 9B illustrates manifold 96 at proximal region 90 p of stretchableimplant system 90. Manifold 96 is comprised of fitting 103, advancer104, and flange 105. Outer surface of inner member 97 is sealinglyattached to inner wall 103 b of fitting 103. Lumen 101 of inner member97 is in fluid communication with lumen 102 a of fitting 103. Fitting103 is comprised of standard luer fitting 106 b at proximal end of lumen102 a. Shaft 92 is fixedly attached to flange 105, flange is heldcaptive within groove 104 a of advancer 104, flange is slideable withingroove 104 a and flange is slideable over inner member 97 by means ofthrough hole 105 a. In an alternate embodiment where length ofstretchable stent is changed by applying torque to the stent, flange 105is fixedly bonded to advancer 104. Advancer is slideably attached tofitting 103 by means of threads 104 t and 103 t integral with advancer104 and fitting 103 respectively. Rotation of advancer 104 displacesshaft 92 relative to inner member 97, causing tensile or compressileforces to be transmitted through retainers 95 p, 95 d and tabs 16 toimplant 94. Handle 106 houses seal 107 that is sealingly slideable overshaft 92. In a transport position, handle 106 and advancer 104 arespaced apart and sheath 93 covers stent 94 to prevent prematuredeployment of stent 94. When handle 106 and advancer 104 are movedtoward each other, sheath 93 slides proximally relative to catheter 92and inner member 97, uncovering self expanding stent 94, therebypermitting stent to deploy by radially expansion. Optionally, handle 106may be provided with a lock (not shown) to limit axial movement ofhandle relative to catheter shaft 92 prior to deployment of stent 94.

Fitting 103, advancer 104, and flange 105 have substantially the sameconstruction, dimensions, and function as Y-fitting 63, advancer 64, andflange 65 respectively described above in conjunction with FIG. 6.Handle 106 may be comprised of the same materials as fitting 103,advancer 104, or flange 105 and may comprise an annular groove along theinner diameter to house seal 107. Seal 107 may be comprised ofelastomeric materials such as butyl rubber, silicone rubber, Viton,C-flex, or other materials and may be molded, cut from sheet, or madeusing other processes known in the art. Inner member 97 and shaft 92 areattached to fitting 103 and flange 105 respectively in substantially themanner as inner member 57 and catheter 52 are attached to Y-fitting 63and flange 65 respectively described above in conjunction with FIG. 6.Optional strain relief, access port and sealing means, or both may beprovided on flange 105 or handle 106 as described above in conjunctionwith FIG. 6.

Optionally, system 90 is comprised of stretchable stent retainer 95 s asillustrated in FIG. 9C. Stretchable stent retainer influences stretchingcharacteristics of stent 94. Stretchable stent retainer is fixedlyattached to distal retainer 95 d and proximal retainer 95 p by molding,fusing, adhesive bonding, welding, or other means. Stretchable stentretainer is slideably attached to stent 94 by means of tabs 99. In someembodiments, tabs 99 protrude from surface of retainer 95 s and intocells 18, 18 a, 18 b, 18 c, 18 d, or 18 f of stents 10, 20A, 20B, 20C,20D, or 20F respectively. Stretchable retainer 95 s is axially stretchesuniformly along its length, preferentially along one or more localizedregion along it's length, or at different rates along one or morelocalized region along it's length. Stretchable stent retainer may becomprised of polymers such as nylon, PEBAX, polyester, PEEK, of metalssuch as stainless steel, nitinol, or of other materials and may befabricated using processes such as molding, extrusion, or otherprocesses. In one embodiment retainer 95 s is a coextruded tubecomprised of nylon 12 tabs 99 and outer shell with a 72D PEBAX innershell. Stretch rate of retainer 95 s may be adjusted by varying the wallthickness of the retainer at various regions along the length of theretainer. In one embodiment retainer 95 s has a uniform wall thicknessover its length and undeployed stent 94/retainer 95 s combinationuniformly stretches along it's length prior to stent deployment. Inanother embodiment retainer 95 s has a locally thin wall thickness overthe distal and proximal thirds of its length and undeployed stent94/retainer 95 s combination preferentially stretches along the distaland proximal regions of retainer prior to stent deployment. In yetanother embodiment retainer 95 s has more one or more distinct regionsof locally thin wall thickness over its length and undeployed stent94/retainer 95 s combination preferentially stretches at pre-programmeddiscrete regions along the length of the stent/retainer combinationprior to stent deployment.

Exemplary methods of using stretchable implant system 90 in a body of apatient are now described. While a stent is chosen as the exemplaryimplant in the method it is understood that the disclosure is notlimited to stent implants.

Using techniques well known in the art, a guidewire GW is percutaneouslyinserted into a patient's blood vessel V and advanced to a region ofinterest in the patient's body. Using imaging techniques such asfluoroscopy the diseased portion of the vessel is identified and astretchable stent system comprised of a stretchable stent 94 having thecorrect length range and diameter range for treating the diseasedportion is chosen. Stretchable implant system 90 is advanced over theguidewire to the treatment site and by using imaging techniques such asfluoroscopy markers 17 at distal end 94 d of stent 94 are positioned ata correct location relative to the diseased portion. Markers 17 atproximal end 94 p of stent 94 are then imaged and stent 94 is stretchedor contracted to the correct length by rotating advancer 104 asevidenced by positions of proximal and distal markers relative todisease length.

Fitting/advancer of stretchable implant system 90 is held stationary andsheath 93 is withdrawn proximally to uncover stent 94 thereby permittingstent to deploy by radial self expansion. System 90 is then withdrawnfrom vessel.

In an alternative method, stretchable implant system 90 may be usedaccording to the exemplary method described for using stretchableimplant system 110.

FIGS. 10A and 10B illustrate the distal and proximal portionsrespectively of an alternate embodiment of a stretchable implant system.Stretchable implant system 110 is comprised of catheter 111 havingstretchable stent 114 mounted on distal region 110 d of catheter.Catheter 111 is comprised of catheter shaft 112, extension rod 116,proximal retainer 115 p, inner member 117, manifold 116 and sheath 113.Catheter shaft 112 is fixedly attached to extension rod 116 andextension rod 116 is fixedly attached to retainer 115 p. The workinglength of catheter, defined as the catheter length distal to handle 126,is contemplated to be from 60 to 200 cm. Inner member 117 is furthercomprised of core rod 117 c, track 117 a, distal tube 117 b, extensiontube 117 s, tip 118, and distal retainer 115 d. Tip 118 and distalretainer 115 d are fixedly attached to distal tube 117 b, distal tube117 b is fixedly attached track 117 a, and track 117 a is fixedlyattached to extension tube 117 s and core rod 117 c. Guidewire lumen 121extends from distal region 110 d of catheter to sheath port 113 s.Sheath 113 is comprised of a single lumen over much of its length aswell as a short bilumen portion in the vicinity of lumen 113 b. Proximalretainer 115 p is slideable over track 117 a, single lumen extensiontube 117 s is slideable within lumen 113 b of sheath 113, and sheath 113is slideable over catheter shaft 112, retainer 115 p and stent 114.Stretchable stent 114 has proximal end 114 p, distal end 114 d, is selfexpandable, and is secured to catheter 111 by compressing the stent to adelivery diameter within sheath 113 with interlock of stent tabs 16 intopockets of retainers 115 p and 115 d. Stretchable stent 114 may be butis not limited to any of the stretchable stents 10, 20A, 20B, 20C, 20D,or 20F discussed previously and unstretched stent lengths of 20 mm to400 mm are contemplated. Manifold 116 is attached to proximal region 110p of catheter and provides means for withdrawal of sheath 113, therebyallowing stent self-expansion, and provides means for stretching stent114. Optionally, a stretchable inner member (not shown) is fixedlyattached to retainers 115 p, 115 d and slideably attached to stent 114as described for stretchable implant system 90.

Catheter shaft 112, retainer 115 p, lumen 121, tip 118, and retainer 115d have substantially the same construction, dimensions, and function ascatheter shaft 52, retainer 55 p, lumen 61, tip 58, and retainer 55 drespectively described above in conjunction with FIGS. 5A to 5C. Distaltube 117 b and extension tube 117 s have substantially the sameconstruction, dimensions, and function as inner member 57 describedabove in conjunction with FIGS. 5A to 5C. Sheath 113 has substantiallythe same construction, dimensions, and function as Sheath 93 describedabove in conjunction with FIGS. 9A to 9B. Track 117 a may be comprisedof polymers and may be manufactured using processes such as insertmolding or reflow techniques. Extension rod 116 and core rod 117 c maybe comprised of metal, engineering polymer, or other materials intendedto resist axial tensile and axial compressive deformation including butnot limited to stainless steel, nitinol, liquid crystal polymer, PEEK,polyimide, metal reinforced materials, fiber reinforced materials, orother materials. Sheath is fixedly attached to handle 126, hassufficient distal hoop strength to constrain self expanding stent 114 ata delivery diameter, has sufficient axial strength to be slid proximallyoff of stent 114 without damage or tensile failure, sufficiently lowcoefficient of friction to allow for movement of the sheath across thecompacted stent, and sufficient flexibility to be advanced as part ofsystem 110 through tortuous vessels. Sheath 113 may be comprised ofpolyester, nylon, PEEK, liquid crystal polymer, polyimide, metalreinforcement, or other materials and may be manufactured at least inpart by extrusion, braiding, or other processes known in the art.

FIG. 10B illustrates manifold 116 at proximal region 110 p ofstretchable implant system 110. Manifold 116 is comprised of fitting123, advancer 124, and flange 125. Outer surface of core rod 117 c isfixedly attached to fitting 123. Fitting 123 is comprised of handle 126b at proximal end of fitting 123. Shaft 112 is fixedly attached toflange 125, flange is held captive within groove 124 a of advancer 124,flange is slideable within groove 124 a and flange is slideable overcore rod 117 c by means of through hole 125 a. In an alternateembodiment where length of stretchable stent is changed by applyingtorque to the stent, flange 125 is fixedly bonded to advancer 124.Advancer is slideably attached to fitting 123 by means of threads 124 tand 123 t integral with advancer 124 and fitting 123 respectively.Rotation of advancer 124 displaces shaft 112 relative to core rod 117 c,causing tensile or compressile forces to be transmitted throughretainers 115 p, 115 d and tabs 16 to implant 114. Handle 126 housesseal 127 that is sealingly slideable over shaft 112. In a transportposition, handle 126 and advancer 124 are spaced apart and sheath 113covers stent 114 to prevent premature deployment of stent 114. Whenhandle 126 and advancer 124 are moved toward each other, sheath 113slides proximally relative to catheter 112 and core rod 117 c,uncovering self expanding stent 114, thereby permitting stent to deployby radial expansion. Optionally, handle 126 may be provided with a useractivated mechanical lock (not shown) to limit axial movement of handlerelative to catheter shaft 112 prior to deployment of stent 114.

Fitting 123, advancer 124, and flange 125 have substantially the sameconstruction, dimensions, and function as Y-fitting 63, advancer 64, andflange 65 respectively described above in conjunction with FIG. 6.Handle 126 may be comprised of the same materials as fitting 123,advancer 124, or flange 125 and may comprise an annular groove along theinner diameter to house seal 127. Seal 127 may be comprised ofelastomeric materials such as butyl rubber, silicone rubber, Viton,C-flex, or other materials and may be molded, cut from sheet, or madeusing other processes known in the art. Core rod 117 c and shaft 112 areattached to fitting 123 and flange 125 respectively in substantially themanner as inner member 57 and catheter 52 are attached to Y-fitting 63and flange 65 respectively described above in conjunction with FIG. 6.Optional strain relief, access port and sealing means, or both may beprovided on flange 125 or handle 126 as described above in conjunctionwith FIG. 6.

Exemplary methods of using stretchable implant system 110 in a body of apatient are now described. While a stent is chosen as the exemplaryimplant in the method it is understood that the disclosure is notlimited to stent implants.

Using techniques well known in the art, percutaneous access to apatient's blood vessel V is established. Using imaging techniques suchas fluoroscopy the diseased portion of the vessel is identified and astretchable stent system comprised of a stretchable stent 114 having thecorrect length range and diameter range for treating the diseasedportion is chosen. A guidewire is either back-loaded or front-loadedinto lumen 121 of stretchable implant system 110 and the position of theguidewire is adjusted such that a short length (typically 10-20 cm) ofthe guidewire extends distally of tip 118. The system/guidewirecombination is advanced through the patients vessel to a region ofinterest in the patient's body. The combination is advanced to thetreatment site and by using imaging techniques such as fluoroscopymarkers 17 at distal end 114 d of stent 114 are positioned at a correctlocation relative to the diseased portion. Alternatively, the diseasedportion is initially crossed by further advancement of the guidewirealone, stretchable implant system 110 is subsequently advanced over theguidewire to the treatment site and by using imaging techniques such asfluoroscopy markers 17 at distal end 114 d of stent 114 are positionedat a correct location relative to the diseased portion. Markers 17 atproximal end 114 p of stent 114 are then imaged and stent 114 isstretched or contracted to the correct length by rotating advancer 124as evidenced by positions of proximal and distal markers relative todisease length.

Fitting/advancer of stretchable implant system 110 is held stationaryand sheath 113 is withdrawn proximally to uncover stent 114 therebypermitting stent to deploy by radial self expansion. System 110 is thenwithdrawn from vessel.

In an alternative method, stretchable implant system 110 may be usedaccording to the exemplary method described for using stretchableimplant system 90.

In a further alternative method, stretchable implant system 50, 70, 90,110 may be used advantageously during delivery of an implant through atortuous path, for example, to a treatment site in the brain. While astent is chosen as the exemplary implant in this method it is understoodthat the disclosure is not limited to stent implants. A stretchableimplant system comprised of a stretchable stent of a length suitable fortreatment of a diseased vessel is chosen. The stent is stretched beforeintroduction of the system into the tortuous path so as to increase thebending flexibility of the system in the region of the unexpanded stent.For example, a stent similar to implant 20C, when stretched, will bemore flexible than when in an unstretched state due to increases in gaps23. The stretchable implant system is then advanced through tortuosityto the treatment site and the stent is axially contracted to the lengthsuitable for treatment of the diseased vessel. The stent is thendeployed and the system is withdrawn from the patient.

FIG. 11 illustrates the distal portion of an alternate embodiment of astretchable implant system. Stretchable implant system 120 is comprisedof catheter 121 having stretchable stent 54 mounted on distal region 120d of catheter, short balloon 129 mounted on distal region of innermember 57, and manifold 56 (illustrated in FIG. 6). Aside from theshortened length of balloon 129 as compared to balloon 59, allcomponents of system 120 have substantially the same construction,dimensions, and function as all components of system 50 described abovein conjunction with FIGS. 5A to 5C and FIG. 6.

Exemplary methods of using stretchable implant system 120 in a body of apatient are now described with the assistance of schematic illustrationsin FIGS. 12A to 12C. While a stent is chosen as the exemplary implant inthe methods it is understood that the disclosure is not limited to stentimplants.

Using techniques well known in the art, percutaneous access to apatient's blood vessel V is established. Using imaging techniques suchas fluoroscopy the diseased portion of the vessel is identified and astretchable stent system comprised of a stretchable stent 54 having thecorrect length range and diameter range for treating the diseasedportion is chosen. A guidewire is either back-loaded or front-loadedinto lumen 61 of stretchable implant system 120 and the position of theguidewire is adjusted such that a short length (typically 10-20 cm) ofthe guidewire extends distally of tip 58. The system/guidewirecombination is advanced through the patients vessel to a region ofinterest in the patient's body. The combination is advanced to thetreatment site and by using imaging techniques such as fluoroscopymarkers 17 at distal end 54 d of stent 54 are positioned at a correctlocation relative to the diseased portion. Alternatively, the diseasedportion is initially crossed by further advancement of the guidewirealone, stretchable implant system 120 is subsequently advanced over theguidewire to the treatment site and by using imaging techniques such asfluoroscopy markers 17 at distal end 54 d of stent 54 are positioned ata correct location relative to the diseased portion. If desired, stent54 can be stretched by rotating advancer 64 prior to initial deployment.Distal end of stent 54 is then deployed by inflating balloon 129. Stent54 is then stretched in-situ by pulling catheter 120 proximally so thatstent 54 becomes tensioned between deployed segment (which is anchoredto the vessel in an expanded form) and proximal retainer 55 p. Astretched portion of stent 54 is then deployed over region D1 byadjusting position of balloon 129 relative to stent and then inflatingballoon 129 (FIG. 12A, with one alternate balloon position shown inphantom). Stent 54 is then contracted in the vicinity of disease D2 andthe contracted portion of stent 54 is then deployed by adjustingposition of balloon 129 relative to stent and then inflating balloon 129(FIG. 12B with contracted portion of stent shown by heavy line). Stent54 is then again stretched in-situ and proximal most stretched portionof stent 54 is then deployed by adjusting position of balloon 129relative to stent and inflating balloon 129 (FIG. 12C, with onealternate balloon position shown in phantom). System 110 is thenwithdrawn from vessel. Optionally, fully deployed stent 54 is furtherexpanded using a balloon long enough to extend over the entire length ofthe expanded stent.

In an alternate exemplary method, May-Thurners syndrome is treated bydeploying compressed stent 54 in the region of crushed vein anddeploying stretched stent 54 in the region of un-crushed vein.

While the various embodiments of the present disclosure have related tostents and stent delivery systems, the scope of the present disclosureis not so limited. It will be appreciated that the various aspects ofthe present disclosure are also applicable to systems for deliveringother types of expandable implants. By way of non-limiting example,other types of expanding implants include anastomosis devices, bloodfilters, grafts, vena cava filters, percutaneous valves, aneurismtreatment devices, occlusion coils, or other devices.

It has been shown how the objects of the disclosure have been attainedin a preferred manner. Modifications and equivalents of the disclosedconcepts are intended to be included within the scope of the claims.Further, while choices for materials and configurations may have beendescribed above with respect to certain embodiments, one of ordinaryskill in the art will understand that the materials and configurationsdescribed are applicable across the embodiments.

1. A medical device comprising: a tubular implant having first andsecond ends and extending for an initial length L1 along a longitudinalaxis; and an implant delivery system comprising: a catheter having anouter tubular member disposed about an inner tubular member, the firstend of the implant operatively secured to the outer tubular member andthe second end of the implant operatively secured to the inner tubularmember; and an actuator mechanism movably coupled to one of the outertubular member and the inner tubular member for changing relativepositions of the outer tubular member and the inner tubular member alonga second axis substantially parallel with the longitudinal axis; whereinchanges in the relative positions of the outer tubular member and theinner tubular member change the initial length L1 of the implant to amodified length L2.
 2. The medical device of claim 1 wherein the implantfurther comprises a plurality of struts having terminal ends, at leastsome of the terminal ends defining a first profile.
 3. The medicaldevice of claim 2 wherein the catheter further comprises: a firstinterlock structure carried by the outer tubular member and comprisingat least one receptacle defining a second profile for enabling axialmovement of one of the terminal ends of the implant relative to theinner tubular member.
 4. The medical device of claim 3 wherein thesecond profile is defined by a wall at least a portion of which extendsat an angle other than substantially normal to the second axis.
 5. Themedical device of claim 2 wherein the catheter further comprises: asecond interlock structure carried by the outer tubular member andcomprising at least one receptacle defining a second profile forenabling axial movement of one of the terminal ends of the implantrelative to the inner tubular member.
 6. The medical device of claim 5wherein the second profile is defined by a wall at least a portion ofwhich extends at an angle other than substantially normal to the secondaxis.
 7. The medical device of claim 1 wherein one of tensile,compressile and torquing force is applied to at least one of the firstand second ends of the implant as the relative positions of the outertubular member and the inner tubular member change.
 8. The medicaldevice of claim 1 wherein the implant is radially expandable about thelongitudinal axis and wherein the implant delivery system furthercomprises an inflatable member carried by the inner tubular member. 9.The medical device of claim 1 wherein the implant delivery systemfurther comprises a guide wire lumen extending proximally from a distaltip of the catheter.
 10. The medical device of claim 9 wherein the guidewire lumen extends at least partially through the outer tubular memberand opens externally thereof distal of a proximal end of the catheter.11. The medical device of claim 1 wherein the implant comprises aself-expanding stent and the implant delivery system further comprises aretractable sheath slidably mounted over the outer tubular member. 12.An implant for insertion into a body lumen comprising: a plurality ofcells at least partially defined by a plurality of struts and aplurality of bridges, selected of the cells disposed at proximal anddistal ends of the implant and having terminal ends attached thereto,and the implant having an initial length L1 extending along alongitudinal axis and an initial circumference C1 extendingcircumferencially about the longitudinal axis, wherein the implantassumes a deformation circumference C2 having a value within 0% to 10%of a value of the initial circumference C1 following application of adeformation force substantially to the terminal ends thereof.
 13. Theimplant of claim 12 wherein the application of any of tensile,compressile and torque forces to the end terminals results in thetubular body assuming a deformation length L2 having a value between 3%to 50% greater than a value of the initial length L1.
 14. An implantdelivery system for use with a tubular implant having first and secondends and an initial length L1, implant delivery system comprising: acatheter having an outer tubular member movably coupled to an innertubular member in a telescoping manner, a first interlock mechanismoperatively coupled to the outer tubular member for receiving andreleasably retaining the first end the implant; a second interlockmechanism operatively coupled to the inner tubular member for receivingand releasably retaining the second end of the implant; and an actuatormechanism movably coupled to one of the outer tubular member and theinner tubular member for changing relative positions of the outertubular member and the inner tubular member along an axis; whereinchanges in the relative positions of the outer tubular member and theinner tubular member change the initial length L1 of the implant to amodified length L2.
 15. The implant delivery system of claim 14 whereinthe first interlock structure comprises at least one receptacle forenabling axial movement of the first end of the implant relative to theaxis.
 16. The implant delivery system of claim 14 wherein the secondinterlock structure comprises at least one receptacle for enabling axialmovement of the second end of the implant relative to the axis.
 17. Amethod for placement of an implant within a body lumen comprising: A)providing an implant having a generally tubular shaped body defining anumber of cells and extending for an initial continuous length L1 alongan axis; B) advancing the implant with a delivery catheter to a sitewithin the body lumen; C) modifying the length L1 to a second continuouslength L2 along the axis with the delivery catheter prior to deploymentat the site within the body lumen, the number of cells defined by thetubular shaped body being the same for both length L1 and length L2; andD) initiating radial expansion of the implant about the axis at the sitewithin the body lumen.
 18. The method of claims 17 wherein C) comprises:C1) applying a force selected from the group of tensile, compressile andtorque forces to one of the first and second ends of the implant. 19.The method of claims 17 further comprising: E) deploying the implanthaving the length L2 with the delivery catheter at the site within thebody lumen.
 20. The method of claims 17 wherein the implant has aninitial circumference C1 extending radially about the axis for length L1and a modified circumference C2 extending radially about the axis forlength L2, the modified circumference C2 having a value within 0% to 10%of a value for the initial circumference C1.
 21. An implant forinsertion into a body lumen comprising: a tubular body extending for aninitial length L1 along a longitudinal axis and having and initialcircumference C1 about the longitudinal axis, the tubular bodycomprising: plurality of strut structures and a plurality bridgestructures collectively defining a plurality of cells, selected of theplurality of cells being disposed at proximal and distal ends of thetubular body and having terminal ends attached thereto; one of theplurality of strut structures and bridge structures being capable ofdeformation in a direction tending toward the longitudinal axis of thetubular body when a force substantially parallel to the longitudinalaxis is applied to the end terminals.
 22. The implant of claim 21wherein the application of one of tensile and compressile forces to theend terminals results in the tubular body assuming a deformation lengthL2 and a deformation circumference C2.
 23. The implant of claim 22wherein the deformation length L2 has a value between 3% to 50% greaterthan a value of the initial length L1.
 24. The implant of claim 22wherein the deformation circumference C2 has a value within 0% to 10% ofa value for the initial circumference C1.
 25. The implant of claim 21wherein a yield force of the plurality of bridge structures normal tothe longitudinal axis is less than a yield force of the plurality ofstrut structures normal to the longitudinal axis.
 26. The implant ofclaim 21 wherein a yield force of the plurality of bridge structuresnormal to the longitudinal axis is less than a yield force of theterminal ends normal to the longitudinal axis.
 27. The implant of claim21 wherein a cross sectional area of the plurality of bridge structuresnormal to the longitudinal axis is less than a cross sectional area ofthe plurality of strut structures normal to the longitudinal axis. 28.The implant of claim 21 wherein a cross sectional area of the pluralityof bridge structures normal to the longitudinal axis is less than across sectional area of the plurality of terminal ends normal to thelongitudinal axis.